Tebufenozide; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: September 30, 1998 (Volume 63, Number 189)]
[Rules and Regulations]               
[Page 52169-52174]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se98-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300721; FRL-6033-3]
RIN 2070-AB78

 
Tebufenozide; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of tebufenozide in or on cranberries. This action is in 
response to EPA's granting of emergency exemptions under section 18 of 
the Federal Insecticide, Fungicide, and Rodenticide Act authorizing use 
of the pesticide on cranberries. This regulation establishes a maximum 
permissible level for residues of tebufenozide in this food commodity 
pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996. The 
tolerance will expire and is revoked on September 30, 1999.

DATES: This regulation is effective September 30, 1998. Objections and 
requests for hearings must be received by EPA on or before November 30, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300721], 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-300721], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), 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. 119, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epamail.epa.gov.

[[Page 52170]]

    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 5.1/6.1 file format or ASCII file 
format. All copies of objections and hearing requests in electronic 
form must be identified by the docket control number [OPP-300721]. 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: Stephen Schaible, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Crystal Mall #2, 
1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9362, e-mail: 
schaible.stephen@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
sections 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, in or on cranberries at 0.5 
part per million (ppm). This tolerance will expire and is revoked on 
September 30, 1999. EPA will publish a document in the Federal Register 
to remove the revoked tolerance from the Code of Federal Regulations.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the FFDCA, 21 
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. 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 are 
described below and discussed in greater detail in the final rule 
establishing the time-limited tolerance associated with the emergency 
exemption for use of propiconazole on sorghum (61 FR 58135, November 
13, 1996)(FRL-5572-9).
    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a 
reasonablecertainty that no harm will result from aggregate exposure to 
the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) requires EPA to give special consideration to 
exposure of infants and children to the pesticide chemical residue in 
establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue....''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemptions for Tebufenozide on Cranberries and 
FFDCATolerances

    According to the Applicants, outbreak populations of blackheaded 
fireworms have been observed in recent years, with severe infestations 
occurring last year. Blackheaded fireworms feed on flowers, growing 
shoots and developing fruit, causing yield loss to the existing 
cranberry crop as well as reducing yield to the following year's crop 
by affecting flower bud formation. The most effective strategy to 
manage infestations of blackheaded fireworms is to apply insecticides 
targeting the first instar stage during the second generation. In 
Washington, the loss of parathion in 1995 has left growers without an 
effective registered alternative- chlorpyrifos, diazanon, azinphos-
methyl and acephate are all currently used, but fail to control the 
later instars. Growers do not like to use the organophosphate 
insecticides during the hatch of the second generation of blackheaded 
fireworm for fear of killing pollinating honeybee colonies which are 
placed near the beds at this time. The only two products having better 
safety to bees, Bacillus thurengiensis (Bt) and pyrenone, have poor 
efficacy against fireworm. Tebufenozide is non-toxic to bees and is the 
only available chemical that can control fireworms during midbloom of 
the cranberry crop. EPA has authorized under FIFRA section 18 the use 
of tebufenozide on cranberries for control of blackheaded fireworm in 
Massachusetts, New Jersey and Washington. After having reviewed the 
submission, EPA concurs that emergency conditions exist for these 
states.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of tebufenozide in or on 
cranberries. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) would be consistent with the safety standard 
and with FIFRA section 18. Consistent with the need to move quickly on 
the emergency exemption in order to address an urgent non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is issuing this tolerance without notice and opportunity for public 
comment under section 408(e), as provided in section 408(l)(6). 
Although this tolerance will expire and is revoked on September 30, 
1999, under FFDCA section 408(l)(5), residues of the pesticide not in 
excess of the amounts specified in the tolerance remaining in or on 
cranberries after that date will not be unlawful, provided the 
pesticide is applied in a manner that was lawful under FIFRA, and the 
residues do not exceed a level that was authorized by this tolerance at 
the time of that application. 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.
    Because this tolerance is being approved under emergency conditions 
EPA has not made any decisions about whether tebufenozide meets EPA's 
registration requirements for use on cranberries or whether a permanent 
tolerance for this use would be appropriate. Under these circumstances,

[[Page 52171]]

EPA does not believe that this tolerance serves as a basis for 
registration of tebufenozide by a State for special local needs under 
FIFRA section 24(c). Nor does this tolerance serve as the basis for any 
State other than Massachusetts, New Jersey and Washington to use this 
pesticide on this crop under section 18 of FIFRA without following all 
provisions of EPA's regulations implementing section 18 as identified 
in 40 CFR part 166. For additional information regarding the emergency 
exemption for tebufenozide, contact the Agency's Registration Division 
at the address provided above.

III. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the Final Rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997)(FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action 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 a time-limited tolerance for 
residues of tebufenozide on cranberries at 0.5 ppm. EPA's assessment of 
the dietary exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by tebufenozide are 
discussed below.
    1. Chronic toxicity. EPA has established the Reference dose (RfD) 
for tebufenozide at 0.018 milligrams/kilogram/day (mg/kg/day). This RfD 
is based on a No Observed Adverse Effect Level (NOAEL) of 1.8 mg/kg/
day, taken from a chronic feeding study in dogs. An uncertainty factor 
of 100 was used.
    2. Carcinogenicity. Tebufenozide has been classified by the Agency 
as a Group E, ``no evidence of carcinogenicity for humans,'' chemical.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.482) for the residues of tebufenozide, in or on a variety of 
raw agricultural commodities. Risk assessments were conducted by EPA to 
assess dietary exposures and risks from tebufenozide as follows:
    i.  Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1 day or single exposure. This is not the case with this chemical.
    ii. Chronic exposure and risk. Using conservative Theoretical 
Maximum Residue Contribution (TMRC) assumptions, chronic dietary 
exposure from the published and proposed uses of tebufenozide was 
calculated to represent 31% of the RfD for the U.S. population; the 
subgroup most highly exposed, non-nursing infants less than 1 year old, 
has a TMRC which represents 80% of the RfD. Because of the assumptions 
that 100% of each commodity will have tebufenozide residues and that 
these residues will be at tolerance level, the resulting exposure and 
risk values should be viewed as overestimates.
    2. From drinking water. Submitted environmental fate studies 
suggest that tebufenozide is moderately persistent to persistent and 
mobile. Thus, tebufenozide could potentially leach to groundwater and 
runoff to surface water under certain environmental conditions. There 
is no established Maximum Contaminant Level (MCL) for residues of 
tebufenozide in drinking water, nor have drinking water Health 
Advisories (HAs) been issued.
    Using Generic expected environmental concentration (GENEEC) 
(surface water) and SCIGROW (groundwater) models, the Agency has 
calculated Tier I Estimated Environmental Concentrations (EECs) for 
tebufenozide for use in human health risk assessments. These values 
represent the upper bound estimates of the concentrations of 
tebufenozide that might be found in surface and ground water assuming 
the maximum application rate allowed on the label. Due to the wide 
range of aerobic soil half-life values, GENEEC and SCIGROW were run 
based on aerobic half-lives of 66 (California Loam) and 729 (worst case 
soil with low microbial activity) days.
     Chronic exposure and risk. Using the GENEEC model, chronic surface 
water concentrations are 13.3 parts per billion (ppb) and 16.5 ppb for 
the half-lives of 66 and 729 days, respectively. Chronic groundwater 
concentrations using the SCIGROW model were calculated to be 0.16 ppb 
and 1.04 ppb, respectively.
    Since there are no acute dietary endpoints for this chemical, 
drinking water levels of concern (DWLOCs) for tebufenozide in drinking 
water were calculated for the chronic exposure scenario only. The 
chronic DWLOCs for tebufenozide were calculated by subtracting from the 
RfD the chronic exposure attributable to food, multiplying this value 
by a body weight default, and dividing this multiple by a drinking 
water consumption value. The Agency assumes that 2 liters of drinking 
water are consumed each day by adults, and 1 L/day by children. The 
Agency's default body weights are 70 kg for males, 60 kg for females, 
and 10 kg for children. Using these assumptions, chronic DWLOCs were 
calculated to be 480 ppb for adult males, 370 for females 13+ years old 
and nursing, and 72 ppb for children ages 1 through 6 years old.
    3. From non-dietary exposure. Tebufenozide is not currently 
registered for use on any residential non-food sites. Therefore, there 
is no chronic, short- or intermediate-term exposure scenario.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
considers ``available information'' concerning the cumulative effects 
of a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    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. For more information regarding EPA's 
efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the Final Rule for Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997).

[[Page 52172]]

C. Aggregate Risks and Determination of Safety for U.S. Population

    1. Chronic risk. Using the TMRC exposure assumptions described in 
Unit II.B. of this preamble, EPA has concluded that aggregate exposure 
to tebufenozide from food will utilize 31% of the RfD for the U.S. 
population. The major identifiable subgroup with the highest aggregate 
exposure is non-nursing infants less than one year old (discussed 
below). EPA generally has no concern for exposures below 100% of the 
RfD because the RfD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. Estimated upper-bound concentrations of 
tebufenozide in surface water and ground water are below the calculated 
drinking water levels of concern for all population subgroups of 
concern.
    2. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure.
    3. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to tebufenozide residues.

D. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- i. In general. 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 maternal pesticide exposure during gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability of mating 
animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a margin of exposure (MOE) analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard MOE and uncertainty factor (usually 100 for combined 
inter- and intra-species variability)) and not the additional tenfold 
MOE/uncertainty factor when EPA has a complete data base under existing 
guidelines and when the severity of the effect in infants or children 
or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
    ii. Developmental toxicity studies. In both the rat and rabbit 
studies, there was no evidence of maternal or developmental toxicity; 
the maternal and developmental toxicity NOAEL in each study was 1,000 
mg/kg/day.
    iii. Reproductive toxicity study. Two 2-generation reproduction 
studies in rats have been submitted to the Agency. In a 1993 study, the 
parental systemic NOAEL was 10 ppm (0.8/0.9 mg/kg/day for males and 
females, respectively) and the LOAEL was 150 ppm (11.5/12.8 mg/kg/day) 
based on decreased body weight, body weight gain, and food consumption 
in males, and increased incidence and/or severity of splenic 
pigmentation. In addition, there was an increased incidence and 
severity of extramedullary hematopoiesis at 2,000 ppm. The reproductive 
NOAEL was 150 ppm and the LOAEL was 2,000 ppm (154.8/171.1 mg/kg/day, 
respectively) based on an increase in the number of pregnant females 
with increased gestation duration and dystocia. Effects in the 
offspring consisted of decreased number of pups per litter on postnatal 
days 0 and/or 4 at 2,000 ppm, with a NOAEL of 150 ppm.
    In a 1995 study, the parental NOAEL was 25 ppm (1.6/1.8 mg/kg/day, 
for males and females, respectively) and the LOAEL was 200 ppm (12.6/
14.6 mg/kg/day), based on histopathological findings in the spleen. 
Additionally, at 2,000 ppm (126/143.2 mg/kg/day, respectively), 
treatment-related findings included reduced parental body weight gain 
and increased incidence of hemosiderin-laden cells in the spleen. 
Columnar changes in the vaginal squamous epithelium and reduced uterine 
and ovarian weights were also observed at 2,000 ppm, but the 
toxicological significance was unknown. For offspring, the systemic 
NOAEL was 200 ppm, and the LOAEL was 2,000 ppm based on decreased body 
weight on postnatal days 14 and 21.
    iv. Pre- and post-natal sensitivity. The Agency has concluded that 
the submitted studies provide no indication of increased sensitivity of 
rats or rabbits to in utero and/or postnatal exposure to tebufenozide. 
No maternal or developmental findings were observed in the prenatal 
developmental toxicity studies at doses up to 1,000 mg/kg/day in rats 
and rabbits. In both 2-generation reproduction studies, effects 
occurred at the same or lower treatment levels in the adults as in the 
offspring. Based on this information, the Agency has concluded that the 
10X factor to account for enhanced sensitivity of infants and children 
should be removed.
    v. Conclusion. There is a complete toxicity data base for 
tebufenozide and exposure data is complete or is estimated based on 
data that reasonably accounts for potential exposures.
    2. Chronic risk. Using the exposure assumptions described above, 
EPA has concluded that aggregate exposure to tebufenozide from food 
will utilize 80% of the RfD for non-nursing infants and 60% of the RfD 
for children ages 1 through 6 years old. EPA generally has no concern 
for exposures below 100% of the RfD because the RfD represents the 
level at or below which daily aggregate dietary exposure over a 
lifetime will not pose appreciable risks to human health. Estimated 
upper-bound concentrations of tebufenozide in surface water and ground 
water are below the calculated drinking water levels of concern for all 
population subgroups of concern.
    3. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to tebufenozide 
residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    The metabolism of tebufenozide in/on plants is adequately 
understood. The residue of concern is the parent compound, tebufenozide 
per se as specified in 40 CFR 180.482.

B. Analytical Enforcement Methodology

    The High performance liquid chromatography using ultra-violet 
detection (HPLC/UV) method, TR 34-95-19, is considered adequate for 
enforcement purposes and has been submitted to the FDA for inclusion in 
PAM II.
    The method may be requested from: Calvin Furlow, PRRIB, IRSD 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location and telephone 
number: Rm 101FF, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA 22202, (703-305-5229).

[[Page 52173]]

C. Magnitude of Residues

    Residues of tebufenozide are not expected to exceed 0.5 ppm in 
cranberries as a result of this section 18 use. There are no cattle, 
poultry, or swine feed items associated with this use; consequently 
secondary residues of tebufenozide are not expected in animal 
commodities.

D. International Residue Limits

    There are currently no CODEX, Canadian, or Mexican listings for 
tebufenozide residues; therefore, there are no harmonization issues for 
this action.

E. Rotational Crop Restrictions

    Cranberries are not rotated to other crops; therefore a discussion 
of rotational crop restrictions is not germane to this action.

V. Conclusion

    Therefore, the tolerance is established for residues of 
tebufenozide in cranberries at 0.5 ppm.

VI. 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 November 30, 1998, 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 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.

VII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300721] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, 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 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C) 
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:
    opp-docket@epamail.epa.gov.


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

 VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under FFDCA section 408 
(l)(6). The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This 
final rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as 
specified by Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 
special considerations as required by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994), 
or require OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since tolerances and exemptions that are established 
under FFDCA section 408 (l)(6), such as the tolerance in this final 
rule, do not require the issuance of a proposed rule, the requirements 
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not 
apply. Nevertheless, the Agency has previously assessed whether 
establishing tolerances, exemptions from tolerances, raising tolerance 
levels or expanding exemptions might adversely impact small entities 
and concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance actions published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon

[[Page 52174]]

a State, local, or tribal government, unless the Federal government 
provides the funds necessary to pay the direct compliance costs 
incurred by those governments. If the mandate is unfunded, EPA must 
provide to OMB a description of the extent of EPA's prior consultation 
with representatives of affected State, local, and tribal governments, 
the nature of their concerns, copies of any written communications from 
the governments, and a statement supporting the need to issue the 
regulation. In addition, Executive Order 12875 requires EPA to develop 
an effective process permitting elected officials and other 
representatives of State, local, and tribal governments ``to provide 
meaningful and timely input in the development of regulatory proposals 
containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide to OMB, in a separately 
identified section of the preamble to the rule, a description of the 
extent of EPA's prior consultation with representatives of affected 
tribal governments, a summary of the nature of their concerns, and a 
statement supporting the need to issue the regulation. In addition, 
Executive Order 13084 requires EPA to develop an effective process 
permitting elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit 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 United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 22, 1998.

James Jones,

Director, Registration Division, 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 by adding alphabetically an entry for 
``cranberries,'' to the table in paragraph (b) to read as follows:


Sec. 180.482  Tebufenozide; tolerances for residues.

*        *        *        *       *
    (b) Section 18 emergency exemptions. ***

------------------------------------------------------------------------
                                                     Parts   Expiration/
                     Commodity                        per     Revocation
                                                    million      Date
------------------------------------------------------------------------
                  *        *        *        *        *
Cranberries.......................................    0.5        9/30/99
                  *        *        *        *        *
------------------------------------------------------------------------

*        *        *        *        *

[FR Doc. 98-26001 Filed 9-29-98; 8:45 am]
BILLING CODE 6560-50-F
Tebufenozide; Pesticide Tolerances for Emergency Exemptions

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