[Federal Register Volume 63, Number 189 (Wednesday, September 30, 1998)]
[Rules and Regulations]
[Pages 52169-52174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26001]
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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: [email protected].
[[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:
[email protected].
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:
[email protected].
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