[Federal Register Volume 62, Number 43 (Wednesday, March 5, 1997)]
[Rules and Regulations]
[Pages 9984-9989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5414]
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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.
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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: opp-docket@epamail.epa.gov.
Copies of objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption. Copies of objections and hearing requests will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All copies of objections and hearing requests in electronic form must
be identified by the docket number [OPP-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 Libraries.
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: cimino.pat@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, pursuant to section 408(e) and (l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
and (l)(6), is establishing 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
[[Page 9985]]
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
[[Page 9986]]
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
[[Page 9987]]
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 tebufenozide residues.
E. Determination of Safety for Infants and Children
In assessing the potential for additional sensitivity of infants
and children to residues of tebufenozide, EPA considered data from
developmental toxicity studies in the rat and rabbit and a reproduction
study in the rat. The developmental toxicity studies are designed to
evaluate adverse effects on the developing organism resulting from
pesticide exposure during prenatal development to one or both parents.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
Developmental (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.="" [[page="" 9988]]="" 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="" children.="" 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.="" vi.="" conclusion="" 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:="">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, 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
[[Page 9989]]
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.
Peter Caulkins,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.482, 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
